MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367962

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem Hemolysis (1886)

Event Date 04/25/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes device experienced hemolysis.The following information was provided by the initial reporter.The customer stated: it was reported that during literature search it was reported that there was higher rates of hemolytic samples collected using bd vacutainer compared to s-monovette in aspiration mode.

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.Initial reporter state: address information was not able to be obtained, therefore, (b)(6) was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported when using the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes device experienced hemolysis.The following information was provided by the initial reporter.The customer stated: it was reported that during literature search it was reported that there was higher rates of hemolytic samples collected using bd vacutainer compared to s-monovette in aspiration mode.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14290218
• MDR Text Key: 291328630
• Report Number: 1917413-2022-00236
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679621
• UDI-Public: 00382903679621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367962
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1